SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by RETAIL BUSINESS SERVICES , LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

• on damaged or broken skin

When using this product

• keep out of eyes.  Rinse with water to remove

Stop use and ask a doctor if

• rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control right away.

Directions

• apply liberaly 15 minutes before sun exposure
• apply to all skin exposed to the sun
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especialy from 10  a.m. -2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

inactive ingredients

water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, benzyl alcohol, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces.

This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Sport Broad Spectrum SPF 50

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147 1-833-992-3872

Quality guaranteed or your money back.

principal display panel

CAREONE

Compare to Coppertone Sunscreen Lotion Sport

SPORT Sunscreen Lotion

SPF 50

UVA/UVB PROTECTION

Broad Spectrum SPF 50

• Water resistant (80 min)
• Oxybenzone & Octinoxate Free Formula

NET 1.5 FL OZ (44 mL)

INGREDIENTS AND APPEARANCE

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-924
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	90 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1000 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	202.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	640 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
GLYCERIN (UNII: PDC6A3C0OX)
POLYESTER-7 (UNII: 0841698D2F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CHLORPHENESIN (UNII: I670DAL4SZ)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
YELLOW WAX (UNII: 2ZA36H0S2V)
BENZYL ALCOHOL (UNII: LKG8494WBH)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DOCOSANOL (UNII: 9G1OE216XY)
TOCOPHEROL (UNII: R0ZB2556P8)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-924-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2021
2	NDC: 72476-924-20	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2021

Labeler - RETAIL BUSINESS SERVICES , LLC (967989935)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(72476-924)